Generic Xenleta Availability
Last updated on Apr 10, 2025.
Xenleta is a brand name of lefamulin, approved by the FDA in the following formulation(s):
XENLETA (lefamulin acetate - solution;intravenous)
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Manufacturer: HONG KONG
Approval date: August 19, 2019
Strength(s): EQ 150MG BASE/15ML (EQ 10MG BASE/ML) [RLD]
XENLETA (lefamulin acetate - tablet;oral)
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Manufacturer: HONG KONG
Approval date: August 19, 2019
Strength(s): EQ 600MG BASE [RLD]
Is there a generic version of Xenleta available?
No. There is currently no therapeutically equivalent version of Xenleta available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xenleta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent 8,071,643
Issued: December 6, 2011
Inventor(s): Mang; Rosemarie et al.
Assignee(s): Nabriva Therapeutics AG (Vienna, AT)A pleuromutilin derivative compound of general formula (I) ##STR00001##
Patent expiration dates:
- January 16, 2029✓✓
- January 16, 2029
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Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Patent 8,153,689
Issued: April 10, 2012
Inventor(s): Mang Rosemarie & Heilmayer Werner & Badegruber Rudolf & Strickmann Dirk B. & Novak Rodger & Ferencic Mathias & Bulusu Atchyuta Rama Chandra Murty
Assignee(s): Nabriva Therapeutics AGDisclosed are pleuromutilin derivatives of formula (I)
Patent expiration dates:
- March 19, 2028✓✓
- March 19, 2028
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Process for the preparation of pleuromutilins
Patent 9,120,727
Issued: September 1, 2015
Inventor(s): Riedl Rosemarie & Heilmayer Werner & Spence Lee
Assignee(s): NABRIVA THERAPEUTICS AGProcess for the preparation of a compound of formula I
Patent expiration dates:
- May 23, 2031✓✓
- May 23, 2031
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- August 19, 2024 - NEW CHEMICAL ENTITY
- August 19, 2029 - GENERATING ANTIBIOTIC INCENTIVES NOW
More about Xenleta (lefamulin)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (1)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antibiotics
- Breastfeeding
- En español
Patient resources
- Xenleta oral/injection drug information
- Xenleta (Lefamulin Intravenous) (Advanced Reading)
- Xenleta (Lefamulin Oral) (Advanced Reading)
Professional resources
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
